Federal Agency Perspectives on Clinical Trial Eligibility: Spring 2018

“Most current [breast cancer] clinical trials only enroll what I call the metastatic cancer ‘Olympians:’ the healthiest of the dying, those who are on their first or second line of therapy, who have limited metastases, who don’t have brain mets, who don’t have other diseases like diabetes or high blood pressure,” Dr. Kelly Shanahan, an obstetrician-gynecologist, activist, consumer reviewer for the Department of Defense Cancer Research Program and patient with stage 4 breast cancer said in an interview via email.1

Dr. Shanahan’s description matches many of the concerns voiced in a series of presentations at a  workshop, convened by the Duke-Margolis Center for Health Policy under a cooperative agreement with FDA, on April 16. The session presented federal agency perspectives on eligibility criteria for inclusion and exclusion in clinical trials.

Strict eligibility criteria factor into increases in the length of clinical trials. According to presenter Dr. Catherine Spong, Acting Director of the National Institute for Child and Human Development at the National Institutes of Health (NIH), pregnant women, children, people with intellectual and physical disabilities and older people (up to 59% of the US population) are not included in research studies.2

Spong CY, Bianchi DW. Improving Public Health Requires Inclusion of Underrepresented Populations in Research. JAMA. 2018;319(4):337–338. doi:10.1001/jama.2017.19138

Deidra Crews, MD, a nephrologist at Johns Hopkins University, presented data on an exclusion criterion that leaves out over 30 million people. These are people who have chronic kidney disease. Only 700,000 of these people are being treated for end stage renal disease (ESRD). Most people with kidney damage do not go on to ESRD. Due to the complex nature of kidney disease, restrictive enrollment criteria excluding a large part of the population are common in randomized clinical trials.2

Dr. Kaveeta Vasisht, Medical Officer in the Office of Medical Policy at the FDA, confirmed Dr. Crews assertions. In a review of 38 clinical trials, her team found that 82% of the trials had a renal or liver based exclusions and 80% allowed investigators to use their discretion in excluding potential participants.2

In another presentation, Marie Bernard, Deputy Director of the National Institutes of Aging at NIH, presented a study on older adult inclusion in clinical trials. They found that even in studies of diseases that are highly prevalent in older people, clinical trials often excluded subjects based on age with 27% of studies setting an arbitrary upper age limit. Another factor that excluded older patients was co-morbidities like hypertension, diabetes or cancer and taking multiple medications as treatment.2

Strict eligibility criteria factor into the increased length of clinical trials. According to the NIH, more than 80% of clinical trials in the US fail to meet their enrollment timelines. The National Academy of Medicine raised significant concerns in an article on the pharmaceutical industry published in October 2017. The organization stated that inefficiencies in drug development, especially rapidly increasing R&D costs and reduced output, could impact the industry to the extent that approval and production of new medicines will not be sufficient to finance future research and development.3

Their concerns are validated by studies conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD). For example, Tufts CSDD found that the time it takes to complete clinical trials has grown by 15% over the last 10 years to an average of 6.8 years.4

Even if the criterion for eligibility for clinical trials are loosened, recruitment issues may still negatively affect the planned deadlines for clinical trial completion and cost companies.  Opportunities to reach patients through social media and communities like Inspire can make a difference. Read about Inspire Recruit to learn more.

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1 M.K. Shanahan, MD, (personal communication, March 21, 2018).

2 https://healthpolicy.duke.edu/events/evaluating-inclusion-and-exclusion-criteria-clinical-trials

Video at https://youtu.be/-0UsjxALvBk

3 https://nam.edu/its-time-to-harmonize-clinical-trial-site-standards/